One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Responsibilities:

Global Regulatory Strategy Lead (GRTL), Oncology will have leadership responsibility for global regulatory strategy for indications within the Hematology portfolio with opportunities to work on solid tumor across the matrix organization, depending on workload/available opportunities.

Support the preparation of, and participate in / lead (as appropriate), key HA interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries.

Drive the creation and execution of the global submission plan. Formulate integrated global submission plan for simultaneous filings and communicate rationale for deviation from simultaneous submissions.

Background and Experience:

Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience. Understanding of scientific content and complexities. A good knowledge of Oncology drug development is desired. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for drug development and approval.

Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.

Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.

Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.

Ability to broadly represent GRS/GRA functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.